A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Percent Excess Weight Loss

Absolute Weight Loss

Change in BMI

Change in Percent Body Fat (DEXA)

Change in Percent Body Fat (Impedence)

Change in Lipid Panel (chol, triglycerides, LDL, HDL

Urinary pH

3 day dietary diary

fasting glucose

OGGT with insulin

OGGT with FFA and gut peptides

gastric emptying

Secondary Outcome Measures:

adverse events

Estimated Enrollment:

30

Study Start Date:

September 2005

Study Completion Date:

December 2008

Detailed Description:

30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of >35 with at least one obesity related comorbidity or a BMI between 40 and 45. Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline.

Thereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.

Eligibility

Ages Eligible for Study:

25 Years to 55 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

male or female age 25-55

BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity

Stable weight for the last 3 months

willing to use contraceptives

motivated to lose weight

a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight

fully ambulatory

Exclusion Criteria:

sign of prior major abdominal surgery

history of or signs and /or symptoms of gastro-duodenal ulcer disease

abnormal vagus nerve testing

current use of a list of medication

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285220